November 7，Ministry of Industry and Information Technology、National Development and Reform Commission、Department of Science and Technology、Business Department、The National Health and Family Planning Commission and the 6 departments of the State Food and Drug Administration jointly released the "Guide to the Medical Industry Development Planning" (hereinafter referred to as the "Planning Guide")。

 

  "Planning Guide" is mainly from 8 aspects for & ldquo; 135 & rdquo;

 

  1 --- Industry scale

 

  Main business income maintains a medium and high -speed growth，The average annual growth rate is higher than 10%，The proportion of the industrial economy has increased significantly。

 

  2 --- Technical Innovation

 

  Enterprise R & D investment continues to increase，By 2020，R & D intensity of enterprises above designated size in the industry reached 2%or more。The quality of innovation is significantly improved，New drug registration accounts for drug registration.，A batch of high -quality innovation achievements realize industrialization，New Drug International Registration gets breakthrough。

 

  3 --- Product quality

 

  Drugs、Increased quality standards for medical equipment，Effective implementation of quality management specifications in each link，Product quality and safety guarantee strengthened。Basically complete the quality and efficacy consistency evaluation of the basic drug oral solid -making dharma,。More than 100 preparation companies that have passed the international advanced GMP certification。

 

  4 --- Green Development

 

  Compared with 2015，The energy consumption of the industrial added value of the enterprise units above 2020 decreased by 18%，Unit industrial added value of carbon dioxide emissions decreased by 22%，Unit industrial added value decreases by 23%，Volatile organic matter (VOCS) emissions decreased by more than 10%，Chemical raw material drug green production level has increased significantly。

 

  5 --- Smart Manufacturing

 

  By 2020，Automation of pharmaceutical production process、Informatization level has improved significantly，The key process of large enterprises is basically automated，Manufacturing Execution System (MES) usage rate reaches more than 30%，Build a batch of intelligent manufacturing demonstration workshops。

 

  6 --- Supply Security

 

  National Basic Drugs、Common low -cost drug supply guarantee capacity is strengthened，The shortage of clinical medication has improved significantly，Patent -expired drugs that are urgently needed by clinical need to be used for imitation listing，The national pharmaceutical reserve system is further improved，Emergency research and development and emergency production capacity of response to public health incidents is significantly enhanced。

 

  7 --- Organizational structure

 

  Industry reorganization integration accelerates，Concentration continues to increase，By 2020，The proportion of the top 100 enterprise business income increased by 10 percentage points，Large enterprises have further strengthened the leading role of industry development。

 

  8 --- Internationalization

 

  Stable growth of pharmaceutical exports，Export delivery value accounts for 10%of the proportion of sales revenue。Exit structure improved significantly，Increased export proportion of preparations and medical equipment。Expansion of overseas investment，Deepening of international technical cooperation，International development capacity greatly improves。

 

  On the main task，"Planning Guide" also enhances industrial innovation capabilities、​​Improve quality and safety level、Improve supply guarantee capabilities、Promote green transformation and upgrade、Promoting two -way deep integration and optimizing industrial organizational structure, etc., proposed specific plans。

 

  stake betting appInnovation ability improvement project

 

  1. Construction of the Pharmaceutical Manufacturing Innovation Center。Construction medicine、Medical Device Manufacturing Innovation Center，Integrate government and social investment、Scientific Research Institute and Enterprise R & D power、Clinical research resources of medical institutions、Enterprise industrialization capabilities and other resources，Cooperation with key technical issues around industrial development，Realize 10-15 key technical breakthroughs，Improve the innovation capabilities of the entire industry chain，Promoting innovation -driven development。

 

  2. The construction of a small and micro enterprise innovation and entrepreneurial service platform。Support the construction of a entrepreneurial incubator、Open Lab、Innovation and entrepreneurial service platforms such as science and technology achievement transformation centers，Support small and micro enterprises innovation activities。

 

  3. Pharmaceutical industry venture capital plan。Guide social capital to set up more than 50 pharmaceutical industry venture capital funds，Total scale reaches more than 10 billion yuan，Provide investment and financing support for pharmaceutical technology innovation projects。

 

  4. Medical R & D data and public resource platform construction。Support the construction and integrated clinical information database、Biological sample library、Compound library、Chinese Medicine Chemical Component Library、Pharmaceutical impurities Standard Standard Library、Pharmaceutical bag material additive database，Implement data and resource open sharing，Provide services to the entire industry's pharmaceutical research and development。

 

  Product Quality Upgrade Project

 

  1. Chemical generic drug quality upgrade plan。Comprehensive implementation of the quality and efficacy consistency evaluation task of the basic drug oral solid preparation，Support large -scale technical transformation and quality upgrade for large variety of generic drugs，Support the development and application of new medicinal accessories。

 

  2. 2. Chinese medicinal materials resources sustainable use plan。Carry out the census of national Chinese medicine resources，Establishing a dynamic monitoring and technical service network of traditional Chinese medicine resources，Establishing a Chinese medicine variety resources protection system，Protective medicinal resources and biological diversity，Guide enterprises to build a standardized planting and breeding base for Chinese medicinal materials。

 

  3. The quality improvement plan of traditional Chinese medicine。Implementation of the development project of traditional Chinese medicine，Support Chinese medicine drinking tablets、Basic medicine for Chinese medicine、The quality of key products such as Chinese medicine injections improves the quality of key products;，Building the entire process traceability system for the construction of Chinese medicinal materials。

 

  4. The vaccine quality improvement plan。Mainly key varieties of immune planning vaccine，Development Multi -Union、Multi -price vaccine，Technical upgrade and production process optimization of existing vaccines，Improve the quality of the quality of the production process，Improve circulating cold chain traceability system，Guarantee vaccine quality and safety。

 

  5. Medical equipment quality improvement plan。Promoting the basic、The quality standard for the quality of generality and high -risk medical device，Support medical device enterprises to improve technology level，Carry out product clinical quality verification，Improve stability and reliability。

 

  Pharmaceutical supply guarantee project

 

  1. Construction of drug production and supply information system。Promote the production statistics of drugs between departments、Bidding purchase、Clinical Medicine、Medical insurance payment and other information system interconnection and sharing，Support for ensuring drug supply。Create a drug shortage early warning system，Monitoring key variety production and supply，Pre -judgment drug supply shortage，Release early warning information。

 

  2. Small variety drug concentrated production base construction。Choose a strong comprehensive strength、High quality management level、Production enterprises with a concentrated concentration of drugs for small varieties，Layout 3-5 small varieties of drugs for centralized production bases nationwide，Improve the supply and guarantee capabilities of a batch of small varieties。

 

  3. Emergency drug research and development and industrialization base。For newly developing sudden infectious diseases，and other emergency needs that endangers national public health and safety，stake betting appRelying on conditional enterprises and scientific research institutions，Pharmaceuticals to build military and civilians、Quick research and development and production base of vaccine，Meeting the needs of disease prevention and control。

 

  4. Construction of the pharmaceutical reserve information system。Realize the interconnection of the central government and the local medical reserve information system，Complete reserve information monitoring and data query online、Reserve plan to issue、Reserve varieties real -time scheduling，Improve emergency response ability。

 

  Medicine Green Development Engineering

 

  1. Green production technology development and application。Focusing on chemical raw materials，Development and application of toxic and harmful raw materials alternative、Biological synthesis and biocity、Clean production technology such as solventless separation，Improve the level of three waste governance levels such as volatile organic matter without tissue emissions control level and fermentation bacteria;，Strengthen the management of production input products，Improve the non -medicinal parts of Chinese medicinal materials、Comprehensive utilization level of production waste in traditional Chinese medicine industry。

 

  2. Construction of Green Factory Demonstration Project。Support to build a batch of low energy consumption in accordance with international advanced standards、Low emission green demonstration factory，Promote the transformation of clean production and energy saving and emission reduction technology。

 

  3. Chemical raw material medicine green park construction。Choose an suitable area with strong environmental carrying and environmental protection capabilities，Construction of 3-5 chemical raw materials and drug cycle economic parks，Promoting the development of the production cluster of raw and drugs。

 

  Medicine Intelligent Manufacturing Project

 

  1. The development and application of the medical management information system。Support the development of a number of characteristics in line with the characteristics of the pharmaceutical industry，Application in R & D、Production、Management information system for quality management，The focus includes automated batch control technology、Manufacturing Execution System (MES)、Process Analysis Technology (PAT)、Process Knowledge Management System (PKS), etc.，Analysis of the operation around the key process unit、Learning、Decision、Intelligent management system for execution capabilities。

 

  2. Construction of drug intelligent production workshops。Support the construction of more than 20 raw materials、Demonstration workshop of intelligent production of preparations，Comprehensive application of various information technology、Equipment and Management System，Realize the automation and intelligence of the production process; support the construction of more than 5 applications for continuous manufacturing technology for more than 5 applications，Exploring the transformation from intermittent to continuous production。

 

  3. Construction of the automated production workshop of medical device。Support the construction of more than 10 automated production demonstration workshops for the characteristics of discrete manufacturing of medical equipment，Change most medical devices with manual assembly、The condition of manual testing is mainly，Improve the level of mechanical assembly，Implementing automated material distribution、Quality detection and custom production，The system improves the stability and reliability of medical devices。

 

  International competitiveness improvement project

 

  1. Internationalization strategy of preparations。Support the construction of a group of high -standard preparation production bases，Pass the European and American GMP certification。Encourage new medicine、Chemical imitation drugs、Chinese medicine、International registration of biological similar drugs，Achieve 3-5 new drugs and more than 200 chemical generic drugs in the market in developed countries。Encourage enterprises to improve the international market operation capabilities，Establish a sales channel for the international market，Cultivate Chinese manufacturing brand。

 

  2. Construction of overseas production bases。Support enterprise acquisition or invest in the construction of overseas chemicals、Preparation、Chinese medicinal materials production base，Promoting international cooperation of production capacity，Make full use of overseas environmental resources，Better to serve the local market。

 

  3. International technical exchanges and cooperation。Support international talent and technical exchange，Introduction and output stake sports betting appadvanced products and technology，Encourage foreign companies to set up research and development in the country、Production base，Carry out the clinical trial of the New Drug International Multi -Center。

 

  Development for key areas，"Planning Guide" specifies biopharmaceuticals、Development direction of chemical drugs and Chinese medicine。

 

  1. Biopharmaceutical

 

  1. antibody drugs。Focus on the development of tumors、immune system disease、antibody drugs for cardiovascular disease and infectious diseases，PCSK9 inhibitors for treating hypertrophymia、Tumor immunotherapy drugs PD-1/ PD-L1、New drugs with outstanding clinical value such as osteoporosis。Accelerate the antibody coupling drug、Dual -function antibody、R & D of new antibodies such as antibody fusion protein。Promoting the industrialization of large -scale biomedicals with large number of clinical demand，The focus is on TNF-& Alpha;、CD20、VEGF、Her2、EGFR and other target products，Improve patients with medicine and sex。

 

  2. Reorganized protein drugs。Focus on diabetes、Virus infection、Tumor and other diseases，Develop low immunogenicity、Good stability、Strong targeted、Long -term effect、New products with high biological utilization。According to the needs of diabetes in my country，Improve long -acting insulin、Premix insulin industrialization level，Accelerate the development of new varieties such as analogy-1 (GLP-1) analogs。Promote the reorganized human white protein with major needs、Industrialization of genetic restructuring coagulation factor and other products。Establish a quality control system that is in line with international standards，Actively open up the international market。

 

  3. Vaccine。Focus on the development of high pathogenic flu、malaria、Dengue fever、tuberculosis、AIDS、Ebola、Zhaka、Middle East respiratory syndrome and other major infectious disease vaccines，Improve the emergency research and development and industrialization capabilities of vaccines。Accelerate the 13 -valent pneumonia binding vaccine、Cervical cancer vaccine、respiratory tract syndicocytosis vaccine and other clinical urgent need of product development and industrialization。Develop for tumor、immune system disease、Therapeutic vaccines of infectious diseases and new types of vaccine and new cell matrix。Develop multi -federation and multi -price vaccine、Gene engineering vaccine、Virus vector vaccine、Nucleic acid vaccine and other new vaccines，Realize the upgrade of some immunization planning vaccine。

 

  4. Nucleic acid drugs and cell therapy products。Focus on the development of RNA interference drugs、Gene therapy drugs and cell therapy products such as stem cells and immune cells，Including cell therapy products such as CAR-T。

 

  5. Industrialization technology。Key development of large -scale development、High expression antibody production technology，antibody puppet drugs、Dual -functional antibody and other new antibody preparation technology，Reorganized protein long -acting agent technology，Large -scale influenza vaccine -based high -yield technology based on cell matrix，Cell therapy product preparation technology，Reorganized human albumin's large -scale expression and purification technology，Analysis and detection technology of extreme trace impurities。For key development products，Establish quality control technology that is in line with international advanced levels。Improve the no -serowless protein medium、Protein separation and purification medium、The production level of important raw and auxiliary materials for production such as stabilizers and protective agents。

 

  2. Chemical medicine

 

  1. New chemical drugs。Follow the development trend of international pharmaceutical technology，Develop the development of new drugs for major diseases，Focus on the development of malignant tumors、Cardiovascular and cerebrovascular disease、Diabetes、Psychiatric disease、Neurological degenerative disease、Autoimmune disease、Drug -resistant infection、Innovative drugs for diseases such as virus infection，Especially using new targets、New drugs of the new action mechanism。The trend of disease segmentation and precision medical treatment，Development of new medicines for specific diseases in my country、New Compound Preparation、Diagnostic accompanying products。

 

  2. Chemical generic drugs。Accelerate clinical urgent needs、New patent -expired drugs for generic drug development，Improve patients with medicine and sex。Improve the quality level of generic drugs，Focus on combining the quality and efficacy consistency evaluation of generic stake sports betting appdrugs to improve the level of oral solid preparation production technology and quality control level。

 

  3. High -end preparation。Focus on the development of lipid bodies、Fat micro -ball、Nano -preparations and other new injections to the medication system，Oral quick interpretation、Slow control interpretation、Multi -particle system and other oral adjustments to the medication system，Drug system，Children and other special population applicable dosage forms，Promote the high -end preparation to reach international advanced quality standards。

 

  4. Clinical shortage drugs。Strengthen rare disease medicine、Children's medication and other clinical shortage drug development，Accelerate clinical essential but side effects of drug replacement products。

 

  5. Industrialization technology。Focus on the development and application of raw material crystal control、Ease Method Synthetic、Hand synthesis、Micro -reactor continuous synthesis、Carbon fiber adsorption、Molecular distillation and other new technologies，The harmless treatment of solid waste and other solid waste such as fermentation bacteria and resource utilization technology，The harmless treatment of solid waste and other solid waste such as fermentation bacteria and resource utilization technology，Improving the level of oral solid preparation technology and quality control level。

 

  3, Chinese medicine

 

  1. Materia Medicine。For cardiovascular and cerebrovascular diseases、Autoimmune disease、Maternal and Children's Diseases、Chinese medicine superior diseases such as digestive diseases，Digging the classic famous prescription，Development Compound、New Chinese medicine for effective parts and effective ingredients，Accelerate the precise efficacy、R & D and industrialization of Chinese medicine innovative drugs with high clinical value。For the available varieties，Use modern science and technology to deeply dig clinical value，Clarify the field of advantage therapy，Develop new indications。Effective efficacy after launching drugs、Safety、Re -evaluation of preparation process and quality control，Breakthroughs in the implementation of new drugs for new drugs。

 

  2. Traditional Chinese medicinal materials and Chinese medicine drinks。Focus on the development of endangered scarcity medicinal materials artificial breeding technology，Promote musk、Agarwood、Winter Cordyllaria and other products Wild variable planting and breeding; improve the standardized production and area processing technology of Daizongdao's medicinal materials，Improve the quality of Chinese medicine from the source。

 

  3. National medicine。Promoting the construction of the quality resource library of the ethnic medicine，Systematic research evaluating the safety and effectiveness of ethnic medicine，Improve the production of ethnic medicine、Processing、Preparation and other key technologies，Improve product quality，Cultivate special varieties。

 

  4. Industrialization technology。Focus on the development of Chinese medicine ingredients in large -scale and efficient separation and preparation technology，Slow -control release of the characteristics of traditional Chinese medicine、Drug administered with peel and mucous membranes、New preparation technology such as physical modification and smell，Improve the quality control level of the production process，Improve inspection and testing technology and standards。